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The LIAISON® CMV IgM Serum Control Set (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgM assay on the LIAISON® Analyzer family.

The LIAISON® CMV IgM Serum Control Set (negative and positive) consists of liquid ready-to-use controls in human serum. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.

The controls are designed for use with DiaSorin LIAISON® CMV IgM assay on the LIAISON® analyzer family.

The provided text describes a 510(k) premarket notification for a medical device called the "LIAISON® CMV IgM Serum Control Set." This document focuses on the acceptance criteria and the study that proves the device meets those criteria for this specific product.

It's important to understand that this is a quality control material used to monitor the performance of another assay (the LIAISON® CMV IgM assay), not a diagnostic device itself. Therefore, the "performance" here refers to its stability and ability to function as a reliable control, not diagnostic accuracy in identifying patient conditions.

Based on the provided text, here's the information regarding acceptance criteria and the study:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria with specific numerical targets. Instead, it lists the types of studies conducted to demonstrate that the modified device meets "predetermined acceptance criteria" and "design specifications." The reported "performance" is that it successfully met these criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes (e.g., number of control sets, number of runs, number of replicates) used for the verification and validation (test set) studies. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a 510(k) for a control material, the studies would typically be prospective laboratory-based verification and validation studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable in the context of this device. The "ground truth" for a quality control material is its chemical and immunological behavior and stability, not a diagnosis or clinical outcome. The validation is based on analytical performance studies, not expert consensus on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies involving human interpretation (e.g., radiology images), not for the analytical performance of a quality control material.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. MRMC studies are specific to evaluating diagnostic aids, often AI systems, and how they impact human reader performance. This device is a quality control material for an immunoassay, not a diagnostic or AI-powered system that human readers use directly to interpret patient cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to the performance of the control material itself in the context of the LIAISON® CMV IgM assay. The studies listed ("Commutability," "Precision," "Control Value Assignment," "Control Range Definition," and "Real Time Stability") are inherently "standalone" in that they evaluate the properties of the control material and its interaction with the analyzer and assay without a human "interpretation" component in the process of the control material functioning. It is not an "algorithm" in the sense of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this quality control material is its pre-established composition and expected analytical performance characteristics based on reference methods and the established performance of the LIAISON® CMV IgM assay it controls. It's an internal, analytical "ground truth" rather than a clinical diagnostic one. For example:

• Commutability/Matrix Effect: Related to how the control material behaves similarly to actual patient samples.
• Precision: How consistently the control material yields results within a defined range.
• Control Value Assignment/Range Definition: Based on a rigorous process to determine the expected signal and acceptable variation for the positive and negative controls.
• Stability: Measured by maintaining specified performance characteristics over time.

8. The sample size for the training set

This is not explicitly stated and is not directly applicable in the sense of a machine learning "training set." The development of the control material and the initial characterization of its performance would involve laboratory experiments, but the document doesn't detail the sample sizes of materials used in that developmental phase. The "study that proves the device meets the acceptance criteria" refers to the verification and validation studies, not an AI training process.

9. How the ground truth for the training set was established

Not applicable for a "training set" in the context of AI. For the development and characterization of the control material, the "ground truth" (i.e., the target characteristics and performance) would have been established through:

• Careful formulation and manufacturing processes.
• Protocols for assigning target values and ranges, often using a large number of replicates and statistical methods.
• Comparison to existing reference materials or established clinical samples to ensure it behaves diagnostically like patient samples (for commutability).
• Controlled environmental conditions and repeated testing for stability.

In summary, this document is a 510(k) for a quality control material, not a diagnostic device that performs clinical interpretation or uses AI. Therefore, many of the questions asked (especially those related to human readers, experts, and AI-specific ground truth/training sets) are not relevant to the type of product described or the studies conducted to support its clearance. The focus is on the analytical performance and stability of the control material itself.

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